BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP TIBIAL TRAY

    MDR report key: 6944056 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08574
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 21, 2016
    Report Date
    November 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH: PATIENT WAS BORN IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP LATERAL TIBIAL BEARING, CAT#: 195779, LOT#: 641410. VANGUARD XP MEDIAL TIBIAL BEARING, CAT#: 195850, LOT#: 597010. VANGUARD XP FEMORAL, CAT#: 195205, LOT#: 934930. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08571, 0001825034-2017-08572, 0001825034-2017-08573. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLYETHYLENE EXCHANGE TO ADDRESS INSTABILITY AND ADHESIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723322 VANGUARD XP TIBIAL TRAY PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 677780

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R